An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia | NCT01105793 | Trialant
CompletedInterventionalPhase 2Updated Oct 26, 2011
An Open-Label, MultiCenter Evaluation of the Use of Topically Administered FP1198 in Subjects With Pain Associated With Cyclic Mastalgia
ClinicalTrials.gov ID
NCT01105793
Lead Sponsor
FemmePharma Global Healthcare, Inc.INDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 2
Enrollment
20Estimated
Last Update Posted
Oct 26, 2011Estimated
Start Date
Jun 2010
Primary Completion Date
Jun 2011Actual
Completion Date
Jun 2011Actual
Brief Summary
The purpose of this study is to determine the safety of topical FP1198 for the treatment of moderate to severe cyclic breast pain (cyclic mastalgia) and to examine the clinical activity of FP1198.
Moderate to Severe Cyclic Mastalgia
Danazol
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
menstruating females at least 18 years of age
BMI less than 30
moderate to severe breast pain associated with the menstrual cycle
in good general health
Exclusion Criteria:
pregnant within the last 6 months
has taken in the last 3 months or currently taking hormonal contraception
history of malignancy or currently being treated for cancer of the breast or genital organs
has had breast implants or breast reduction surgery